Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

NCT ID: NCT00599378

Last Updated: 2013-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 373 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2012-06-30

Brief Summary

To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.

Detailed Description

Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population. A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details). The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment. Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls. Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts). Physicians will receive informational fax sheets summarizing all participant phone calls. A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered. The primary outcome will be CRC screening adherence at 120 days. Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Implementation Intentions-based telephone counseling. Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.

Group Type: EXPERIMENTAL

Implementation Intentions-based telephone counseling

Intervention Type: BEHAVIORAL

Implementation Intentions-based telephone counseling

2

Healthy Living information on Physical Activity and Nutrition

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implementation Intentions-based telephone counseling

Implementation Intentions-based telephone counseling

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 50 years of age or older
• at average risk for colorectal cancer
• not up to date with colorectal cancer screening

Exclusion Criteria

• Younger than 50 years of age
• at high risk for colorectal cancer
• up to date with colorectal cancer screening

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Kimberly Engelman, PhD

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Engelman, PhD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kimberly K. Engelman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

1R01CA121016-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11018

Identifier Type: -

Identifier Source: org_study_id